People Who Get Johnson & Johnson Vaccine at Elevated Risk of Guillain-Barré Syndrome: Study

A new study shows that people who receive the Johnson & Johnson COVID-19 vaccine are at increased risk of developing a severe autoimmune disorder that can cause paralysis.

The researchers used data from the Datalink Safety Datalink, which is operated by the Centers for Disease Control and Prevention (CDC). They found (pdf) 21 probable cases, 11 of which have been confirmed, of Guillain-Barré syndrome (GBS) in people who got vaccinated. Most occurred with 13 days of vaccination.

The incidence of confirmed cases per 100,000 person-years was 34.6 within 1 to 21 days after administration, significantly higher than the historical background rate of 2 per 100,000 person-years.

Adjusted rates were also higher than expected and background rates.

The researchers determined that the incidence of GBS was significantly lower among those who received an RNA-based vaccine, Moderna or Pfizer. The rates after those vaccinations were similar to the background rates.

The researchers said the study is validating results from the Vaccine Adverse Event Reporting System (VAERS), an adverse reporting system operated by the CDC and Food and Drug Administration.

A study published in the Journal of the American Medical Association in October, analyzing data from the system, found “small but statistically significant potential safety concerns for Guillain-Barré syndrome after receiving” the Johnson & Johnson vaccine.

The number of GBS cases reported to VAERS after receiving the vaccine as of December 8 was 210.

Kayla Hanson of the Marshfield Clinic Research Institute in Wisconsin completed the new study with the help of scientists from Kaiser Permanente Research and Ambulatory Care Services in Denver and HealthPartners Institute in Minneapolis.

The study was sponsored by the Center for Disease Control. It was published as a preliminary print, or prior to peer review, on the Medrxiv server.

The restrictions included much lower doses of Johnson & Johnson given in the United States than those of Pfizer and Moderna, and excluded stimulant doses.

Johnson & Johnson did not respond to requests for comment.

The company said in a press release this week that GBS “has occurred in some of the people who received the company’s vaccine.” Symptoms begin to appear within 42 days in most people, she added, adding that “the chance of this happening is very low.”

Johnson & Johnson urged people to seek immediate medical attention if any of the following symptoms develop after a vaccine: weakness or tingling, especially in the legs or arms, that gets worse and spreads to other parts of the body; difficulty walking; difficulty with facial movements, including speaking, chewing, or swallowing; double vision or inability to move the eyes; Difficulty controlling bladder or bowel function.

The Food and Drug Administration in July added a Johnson & Johnson vaccine label warning people of its association with a “significant increased risk” of GBS.

However, regulators say the benefits of the vaccine outweigh the risks associated with it.

Jack Phillips contributed to this report.


Zachary Stiber covers US news and stories related to the COVID-19 pandemic. He resides in Maryland.


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